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New treatment option for Cervical Cancer
Official title Assessment of Gemcitabine as Chemoradiotherapy in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease
ClinicalTrials.gov ID: NCT03101995
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for cervical cancer.
Also referred to as Gemzar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- From the global burden of Cervical Cancer (CC), 85% occurs in developing countries, representing 12% of cancer in women. In Mexico CC ranks second in incidence and mortality among women.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Patients who give their written consent to participate in the study.
- Women, 18-70 years of age, considering the following criteria:
- In women of childbearing age: i. Negative serum pregnancy test at baseline (14 days prior to the start of QT-RT). ii. The patient must accept the use...
- Postmenopausal women must meet at least one of the following parameters for eligibility: i. Prior bilateral oophorectomy ii. Age ≥ 60 years iii. Age...
- Diagnosed with CC IB2-IVA, with or without retroperitoneal lymph nodes (para-aortic), smaller than 2 cm.
You likely can't join if
- Patients with prior or concomitant malignancy, except non-melanoma skin carcinoma.
- Patients with diabetes and/or hypertension with retinopathy or albuminuria \>300.
- Patients with evidence of active TB infection.
- Patients infected with Human Immunodeficiency Virus (HIV).
- Patients with a history of Systemic Lupus Erythematosus and other rheumatologic diseases that cause kidney damage.
- Patients with vesicovaginal or vesicorectal fistula at the time of diagnosis.
See the full eligibility criteria
- Patients who give their written consent to participate in the study.
- Women, 18-70 years of age, considering the following criteria:
- In women of childbearing age: i. Negative serum pregnancy test at baseline (14 days prior to the start of QT-RT). ii. The patient must accept the use of any contraceptive method approved by the attending physician...
- Postmenopausal women must meet at least one of the following parameters for eligibility: i. Prior bilateral oophorectomy ii. Age ≥ 60 years iii. Age \< 60 years, with amenorrhea for at least 12 months and levels of...
- Diagnosed with CC IB2-IVA, with or without retroperitoneal lymph nodes (para-aortic), smaller than 2 cm.
- With histologic confirmation of squamous carcinoma, adenosquamous carcinoma, adenocarcinoma or glassy cells carcinoma.
- Without previous treatment and medically able to receive gemcitabine.
- Disease measurable by CT and/or MRI according to RECIST (v1.1) criteria.
- Functional status of 0-3 according to WHO criteria.
- Renal dysfunction defined by glomerular filtration (GF) \<60 ml/min/1.73m2 calculated by the CKD-EPI formula.
- Normal hematologic and liver function, as defined by the following parameters:
- Hemoglobin \> 10g/L. (Transfusion prior to the treatment is allowed to reach this level of hemoglobin).
- Leucocytes \> 4000/mm3.
- Platelets \> 100,000/mm3.
- Total Bilirubin ≤1.5 times the upper normal limit (UNL).
- Transaminases \< 1.5 times the UNL.
- Normal PA chest radiograph.
- Patients with prior or concomitant malignancy, except non-melanoma skin carcinoma.
- Patients with diabetes and/or hypertension with retinopathy or albuminuria \>300.
- Patients with evidence of active TB infection.
- Patients infected with Human Immunodeficiency Virus (HIV).
- Patients with a history of Systemic Lupus Erythematosus and other rheumatologic diseases that cause kidney damage.
- Patients with vesicovaginal or vesicorectal fistula at the time of diagnosis.
- Patients with uncontrolled intercurrent diseases including active infections that contraindicate QT, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, decompensated diabetes, difficult control...
- Concomitant treatment with other experimental drugs.
- Social, family or geographical conditions that suggest a poor adherence to the study. Study discontinuation criteria.
- Evidence of disease progression, if the researcher considers that the patient would benefit more with other therapy.
- At the request of the patient.
- By unacceptable toxicity.
- Pregnancy. Violation of starting criteria. Criteria must be followed punctually. If a patient were inappropriately included, she must be discontinued from the study.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico City, Mexico
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.